ID
25768
Beschreibung
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Serious Adverse Event (SAE)
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- 18.09.17 18.09.17 -
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GlaxoSmithKline
Hochgeladen am
18. September 2017
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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Beschreibung
Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Investigator's Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Number
Datentyp
text
Alias
- UMLS CUI [1]
- C0237753
Beschreibung
Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Reason
Datentyp
text
Alias
- UMLS CUI [1]
- C0566251
Beschreibung
Reason: Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Beschreibung
Onset Date
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Onset Time
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beschreibung
End Date
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
End Time
Datentyp
time
Maßeinheiten
- 24hr:min
Beschreibung
* If subject died, please inform GSK within 24 hours and complete Form D
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschreibung
Event Course
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
Number of Episodes
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschreibung
Intensity
Datentyp
text
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Action taken
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Relationship
Datentyp
text
Alias
- UMLS CUI [1]
- C0439849
Beschreibung
Assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C0220825
Beschreibung
Assessment Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2348235
Beschreibung
If 'YES', Please record on Concomitant Medication form
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschreibung
Ablation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0547070
Beschreibung
Retreatment with study medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0304229
Beschreibung
Recurrence
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034897
Beschreibung
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beschreibung
Laboratory Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Laboratory Test Date
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826641
Beschreibung
Laboratory Value
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Measurement Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Normal Range
Datentyp
text
Alias
- UMLS CUI [1]
- C0086715
Beschreibung
Remarks
Datentyp
text
Beschreibung
Randomization
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschreibung
Randomization Number
Datentyp
float
Alias
- UMLS CUI [1]
- C2986235
Beschreibung
Investigator's Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date of Report
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C1302584
Ähnliche Modelle
Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
C0019994 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0587081 (UMLS CUI-2)